harris teeter 831.000/831aa

harris teeter 831.000/831aa
SPL v14
SPL
SPL Set ID 401e3a7e-54be-47cc-88c3-a343f5cbbd10
Route
oral
Published
Effective Date 2025-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
mineral oil (999 mg)
Inactive Ingredients
tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-05-03

Adverse Reactions

PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 1-800-432-6111 or harristeeter.com

Purpose

Lubricant laxative

Description

PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 1-800-432-6111 or harristeeter.com


Medication Information

Purpose

Lubricant laxative

Adverse Reactions

PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 1-800-432-6111 or harristeeter.com

Other Information

keep tightly closed.  Protect from sunlight

Inactive Ingredients

mixed tocopherols (added as a stabilizer)

Description

PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105 1-800-432-6111 or harristeeter.com

Principal Display Panel

Harris Teeter™

MINERAL OIL

U.S.P.

LUBRICANT LAXATIVE

FOR RELIEF OF OCASIONAL CONSTIPATION

ODORLESS - TASTELESS - COLORLESS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

Questions?

Call 1-888-593-0593

Use

for relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 8 hours

Direction
  • do not take with meals
  • take only at bedtime
  • may be taked as a single daily dose or in divided doses

adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to 12 yeard of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Do Not Use
  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if you are bedridden or aged
Active Ingredient

mineral oil 99.9%

If Breast Feeding,

ask a health professional before use.

When Using This Product

do not take with meals.  Take only at bedtime.

Adverse Reactions Section

PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Stop Use and Ask A Doctor

if you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are
  • presently taking a stool softener laxative
  • taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Structured Label Content

Purpose

Lubricant laxative

Other Information (Other information)

keep tightly closed.  Protect from sunlight

Inactive Ingredients (Inactive ingredients)

mixed tocopherols (added as a stabilizer)

Principal Display Panel (principal display panel)

Harris Teeter™

MINERAL OIL

U.S.P.

LUBRICANT LAXATIVE

FOR RELIEF OF OCASIONAL CONSTIPATION

ODORLESS - TASTELESS - COLORLESS

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION

16 FL OZ (1 PT) 473 mL

Questions?

Call 1-888-593-0593

Use

for relief of occasional constipation (irregularity).  Generally produces bowel movement in 6 to 8 hours

Direction
  • do not take with meals
  • take only at bedtime
  • may be taked as a single daily dose or in divided doses

adults and children 12 years of age and over - 1 to 3 Tablespoons (15 to 45 mL) maximum 3 Tablespoons (45 mL) in 24 hours

children 6 to 12 yeard of age - 1 to 3 teaspoons (5 to 15 mL) maximum 3 teaspoons (15 mL) in 24 hours

children under 6 years of age - do not use, consult a doctor

Do Not Use (Do not use)
  • if you have difficulty swallowing
  • in children under 6 years of age
  • if you are pregnant
  • for a period longer than 1 week
  • if you are bedridden or aged
Active Ingredient (active ingredient)

mineral oil 99.9%

If Breast Feeding, (If breast-feeding,)

ask a health professional before use.

When Using This Product (When using this product)

do not take with meals.  Take only at bedtime.

Adverse Reactions Section (ADVERSE REACTIONS SECTION)

PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105

1-800-432-6111 or harristeeter.com

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if you have rectal bleeding or failure to have a bowel movement after use.  These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • abdominal pain, nausea, or vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • presently taking a stool softener laxative
  • taking any other drug.  Take this product 2 or more hours before or after other drugs.  Laxatives may affect how other drugs work.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)